DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/3/2024 and 11/14/2025 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 16. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the bed" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “a plurality of night’s sleep” in line 8. This a vague and unclear feature as the term “night’s sleep” has not been defined
Claims 2-15 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 2 recites the limitation “to cause a computing device to operate a dCBTI treatment…parameters” in lines 1-2. It is not clear is the limitation is a new instance or refers to the instance mentioned in lines 12-13 of claim 1.
Claim 2 recites the limitations “a computing device” and “a dBCTI treatment” in lines 1-2. It is not clear if these are new instances or refer to the components mentioned in lines 12-13 of claim 1.
Claim 4 recites the limitation “to generate, …dCBTI parameters for the user” in lines 1-2. It is not clear if this is a new instance or refers to the instance mentioned in lines 10-11 of claim 1.
Claim 4 recites the limitation “dCBTI parameters” in line 2. It is not clear if this is a new instance or refers to the components mentioned in lines 10-11 of claim 1.
Claim 6 recites the limitation “to determine that the user…plurality of sleep sessions” in line 1-3. It is not clear is the limitation is a new instance or refers to the instance mentioned in lines 3-4 of claim 4.
Claim 6 recites the limitation “a first threshold probability” in lines 1-2. It is not clear if this is a new instance or refers to the instance mentioned in line 3 of claim 4.
Claim 8 recites the limitation “to generate, …dCBTI parameters for the user” in lines 1-2. It is not clear if this is a new instance or refers to the instance mentioned in lines 10-11 of claim 1.
Claim 8 recites the limitation “dCBTI parameters” in line 2. It is not clear if this is a new instance or refers to the components mentioned in lines 10-11 of claim 1.
Claim 10 recites the limitation “to generate, …dCBTI parameters for the user” in lines 1-2. It is not clear if this is a new instance or refers to the instance mentioned in lines 10-11 of claim 1.
Claim 10 recites the limitation “dCBTI parameters” in line 2. It is not clear if this is a new instance or refers to the components mentioned in lines 10-11 of claim 1.
Claim 11 recites the limitation “to cause a computing device to operate a dCBTI treatment…parameters” in lines 1-2. It is not clear is the limitation is a new instance or refers to the instance mentioned in lines 12-13 of claim 1.
Claim 11 recites the limitations “a computing device” and “a dBCTI treatment” in lines 1-2. It is not clear if these are new instances or refer to the components mentioned in lines 12-13 of claim 1.
Claim 12 recites the limitation "the human-readable text instructions" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the human-readable text instructions" in line 1. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of compact prosecution, claims 12 and 13 will be interpreted as being dependent on claim 11.
Claim 14 recites the limitation “to cause a computing device to operate a dCBTI treatment…parameters” in lines 1-2. It is not clear is the limitation is a new instance or refers to the instance mentioned in lines 12-13 of claim 1.
Claim 14 recites the limitations “a computing device” and “a dBCTI treatment” in lines 1-2. It is not clear if these are new instances or refer to the components mentioned in lines 12-13 of claim 1.
Claim 15 recites the limitation "the normal sleep environment" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 16 and 17 recites the limitation “a plurality of night’s sleep” in line 9. This a vague and unclear feature as the term “night’s sleep” has not been defined
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0020461 (Shelly et al., hereinafter Shelly).
Regarding claim 1, Shelly discloses an insomnia therapy regimen, system and method (title and abstract). Shelly discloses a system (par. 2; 4) with the following components:
one or more sensors (par. 26) configured to:
sense physiological phenomena of a user of the bed (par. 26; Fig. 1);
generate one or more data streams based on the sensing of the physiological phenomena of the user (Fig. 1);
a computing system comprising at least one processor and computer memory (Fig. 1; par. 15, 21, 22, and 43-44), the computing-system configured to:
receive the one or more data streams for a plurality of night's sleep for the user (par. 11, 26, and 29; "plurality of night's sleep for the user" is a unclear as the night's sleep has not been defined further; this features is interpreted merely as data gathered during sleep);
generate, using the one or more data streams, digital cognitive behavioral therapy for insomnia (dCBTI) parameters for the user (par. 7, 30); and
cause a computing device to operate a dCBTI treatment for the user according to the dCBTI parameters (system provides an output to output apparatus like recommendations to the patient; par. 15 and 40-44; Note that "to operate a dCBTI treatment for the user" is interpreted as merely giving out any instructions or suggestions, regarding the suggested therapy as pointed out in the description par. 216 of the present application; Fig. 1; table 2).
Regarding claim 2, Shelly discloses the limitations of claim 1. In addition, Shelly discloses evaluating treatment efficacy and to the user (par. 12-15, 35-44; visual and audio outputs that include changes to therapy to the user can be considered as reports on updated efficacy information to the user as part of the treatment).
Regarding claim 3, Shelly discloses the limitations of claim 1. In addition, any of the output devices connected to the processor, such as visual and audio output devices, can be considered as automated peripheral devices (par. 44).
Regarding claim 4, Shelly discloses the limitations of claim 1. In addition, Shelly shows the determination of thresholds for experiencing insomnia symptoms (par. 14; predicted insomnia severity and symptoms), sleep duration thresholds (par. 11), and sleep efficacy thresholds (par. 11).
Regarding claim 8, Shelly discloses the limitations of claim 1. Shelly further states the updating of the therapies over several sleep sessions of continuous use (par. 13 and 40-45), which can be considered as the determination of the schedule for the delivery of the dBCTI treatment over consecutive sleep sessions.
Regarding claim 10, Shelly discloses the limitations of claim 1. Shelly further discloses in paragraph 28 the process of determining if the therapy is applied to the patient, which can be considered as determining if the user meets the pre-determined criteria for dCBTI candidacy.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0020461 (Shelly et al., hereinafter Shelly).
Regarding claim 9, Shelly discloses the limitation of claim 8. While Shelly does not explicitly state incorporating changes in daylight savings time to the schedule to deliver treatment, Shelly states the updating of the therapies over several sleep sessions of continuous use (par. 7-13 and 40-45). Shelly states that the therapy system includes consideration of environmental stressors (par. 7-9, 15, 29, and 44). Changes from standard to daylight savings time is a type of environmental stressor because it causes a loss of sleep and shortens the sleep period by one hour. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the system of Shelly to include changes in daylight savings time to the schedule of treatment delivery because changes from standard to daylight savings time is a type of environmental stressor.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0020461 (Shelly et al., hereinafter Shelly) in view US 2004/0225179 (Kaplan et al., hereinafter Kaplan).
Regarding claim 11, Shelly discloses the limitations of claim 1 but does not state that the computing system provides to the user human-readable text instructions to adjust behavior or one or more volitional actions. In a related area, Kaplan discloses an automated insomnia treatment system (title and abstract). Kaplan states in paragraphs 98-99 the use of text alert instructions to a user to adjust certain behavioral actions. Kaplan also states in paragraph 89 that the alert conditions can be given via text and is one of several options to instruct the user to perform an action. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Shelly to provide human-readable text instructions as taught by Kaplan as it is one of several known ways to indicate to a human patient to adjust a behavior of an action.
Regarding claim 12, Shelly and Kaplan disclose the limitations of claim 11. Note that while Shelly does not explicitly state shortening a sleep session, Shelly does suggest modifying and optimizing the therapy methods (par. 34 and 40). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to shorten a sleep session as would have been considered as optimizing a therapy variable to produce an optimal result.
Regarding claims 13-14, Shelly and Kaplan disclose the limitations of claim 11. In addition, Shelly discloses the use of several therapy methods that give instructions (par. 34). These include application of therapy or no application of therapy (par. 28), which would meet the limitation of claim 13. Shelly also states the use of output devices connected to the processor, such as visual and audio output devices, which can be considered as automated peripheral devices (par. 44), thus meeting the limitation of claim 14.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0020461 (Shelly et al., hereinafter Shelly) in view of US 2011/0034811 (Naujokat et al., hereinafter Naujokat).
Regarding claim 15, Shelly discloses the limitations of claim 1 including the presence of a bed (par. 26; Sensors are used with a mattress, which suggests the presence of a bed.). However, Shelly does not state that the bed is the normal sleep environment. In a related area, Naujokat discloses a method and system for sleep/wake estimation (title and abstract). Naujokat states in paragraph 21 that recording in a natural sleep environment eases the monitoring of sleep and rest of patients. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Shelly to have the bed as the normal sleep environment in order to ease the monitoring of sleep and rest of patients as taught by Naujokat.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0020461 (Shelly et al., hereinafter Shelly) in view of US 2015/0257697 (Sepah).
Regarding claims 16 and 17, Shelly discloses an insomnia therapy regimen, system and method (title and abstract). Shelly discloses a system (par. 2; 4) with the following components:
a bed for a user to sleep upon (par. 26; Sensors are used with a mattress, which suggests the presence of a bed.);
one or more sensors (par. 26) configured to:
sense physiological phenomena of a user of the bed (par. 26; Fig. 1);
generate one or more data streams based on the sensing of the physiological phenomena of the user (Fig. 1);
a computing system comprising at least one processor and computer memory (Fig. 1; par. 15, 21, 22, and 43-44), the computing-system configured to:
receive the one or more data streams for a plurality of night's sleep for the user (par. 11, 26, and 29; "plurality of night's sleep for the user" is a unclear as the night's sleep has not been defined further; this features is interpreted merely as data gathered during sleep);
generate, using the one or more data streams, digital cognitive behavioral therapy for insomnia (dCBTI) parameters for the user (par. 7, 30); and
cause a computing device to operate a dCBTI treatment for the user according to the dCBTI parameters (system provides an output to output apparatus like recommendations to the patient; par. 40-44; Note that "to operate a dCBTI treatment for the user" is interpreted as merely giving out any instructions or suggestions, regarding the suggested therapy as pointed out in the description par. 216 of the present application; Fig. 1; table 2).
However, Shelly does not state the presence of a remote server to generate digital cognitive behavioral therapy.
In a related area, Sepah discloses methods and systems for mobile, social, behavioral treatments of sleep (title and abstract). Paragraphs [0005]-[00015] describe the use of a remote server to store filter and analyze data and create and modify prescribed cognitive behavioral therapy. Sepah shows that the online platform allows for enhanced compliance via gamification and providing social support and accountability to the participants. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the system of Shelly to transmit the sleep-data to a remote server for generating cognitive behavioral therapy as taught by Sepah in order to enhance compliance via gamification and provide social support and accountability to the participants.
Allowable Subject Matter
Claims 5-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the first threshold probability is an insomnia severity index (ISI) value that defines a severe insomnia AND does not include any of the group consisting of i) no insomnia, ii) mild insomnia, and iii) moderate insomnia.
Regarding claim 6, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the computer system is further configured to provide, as input, sleep-data for the user to an insomnia-risk classifier and receive, as output, the insomnia-risk metric, wherein the insomnia-risk classifier comprises a model defining relationships between sleep-data and insomnia risk.
Claim 7 is dependent on allowable matter from claim 6 and would be allowable once the 112 rejections are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791 /CARRIE R DORNA/Primary Examiner, Art Unit 3791
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